Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020657
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2001-07-11
Brief Title:
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
Treatment of Delayed Nausea What Works Best
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy
PURPOSE This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer
PURPOSE This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer
Detailed Description:
OBJECTIVES
Compare the effectiveness of a 5 hydroxytryptamine 3 5-HT3 receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer
Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients
Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine
Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis
OUTLINE This is a randomized multicenter study Patients are stratified according to center
Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic ondansetron granisetron tropisetron or dolasetron mesylate combined with dexamethasone on day 1
Patients are then randomized to 1 of 3 antiemetic arms
Arm I Patients receive oral prochlorperazine every 8 hours on days 2 and 3
Arm II Patients receive oral ondansetron every 12 hours oral granisetron every 12 hours or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3
Arm III Patients receive oral prochlorperazine as needed up to 4 times per day on days 2 and 3
Quality of life is assessed at baseline and on day 4
PROJECTED ACCRUAL A total of 670 patients will be accrued for this study within 3 years
Compare the effectiveness of a 5 hydroxytryptamine 3 5-HT3 receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer
Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients
Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine
Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis
OUTLINE This is a randomized multicenter study Patients are stratified according to center
Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic ondansetron granisetron tropisetron or dolasetron mesylate combined with dexamethasone on day 1
Patients are then randomized to 1 of 3 antiemetic arms
Arm I Patients receive oral prochlorperazine every 8 hours on days 2 and 3
Arm II Patients receive oral ondansetron every 12 hours oral granisetron every 12 hours or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3
Arm III Patients receive oral prochlorperazine as needed up to 4 times per day on days 2 and 3
Quality of life is assessed at baseline and on day 4
PROJECTED ACCRUAL A total of 670 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P01-0180 | None | None | None |
| URCC-U3901 | None | None | None |